FDA Adverse Event Reporting System (FAERS) Electronic Submissions: To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Category: Pharmacovigilance
CDSCO Revised Pharmacovigilance Guidance on Extending Event Reporting Deadline
Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.